Last updated: December 9, 2022
Sponsor: University of Pennsylvania
Overall Status: Active - Not Recruiting
Phase
3
Condition
Psoriatic Arthritis
Psoriasis And Psoriatic Disorders
Bone Diseases
Treatment
N/AClinical Study ID
NCT05631457
851448
Ages 18-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Psoriatic arthritis meeting CASPAR criteria;
- Active psoriatic arthritis defined by the presence of at least 2 swollen joints OR 1swollen joint and 1 site of active enthesitis OR active dactylitis involving 2 joints
- At least one active psoriasis plaque;
- Using a TNFi or previously used a single TNFi historically and either never respondedor lost response (TNF IR) and planning to switch to a new biologic therapy;
- If using a single oral small molecule/csDMARD (i.e., methotrexate, leflunomide,hydroxycloroquine, sulfasalazine, or apremilast), must be on a stable dose for 4 weeksand remain on a stable dose during the study; Only use of a single OSM/csDMARD isallowed.
- If using NSAIDs, glucocorticoids (<10 mg daily) or topical medications for psoriasis,must be on a stable dose for 4 weeks and remain on a stable dose during the study;
- age 18-80
Exclusion
Exclusion Criteria:
- Prior exposure to golimumab or another non-TNFi biologic (IL12/23i, JAKi, an IL17i, oran IL23i);
- An adverse event that precludes use of another TNFi (development of drug-induced SLE,allergic reaction, serious infection, heart failure symptoms, demyelination at anypoint during use of therapy) or any other contraindication or substantial intoleranceto a TNFi;
- Use of moderate to high dose glucocorticoids (>10 mg).
- Already meet the primary outcome at screening or baseline
- Currently pregnant or actively trying to conceive
Study Design
Total Participants: 300
Study Start date:
February 01, 2023
Estimated Completion Date:
May 31, 2025
Study Description
Connect with a study center
University of Pennsylvania
Philadelphia, Pennsylvania 19104
United StatesSite Not Available

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